Sesen Bio 'Pleased' by Oct. 29 FDA Meeting on Lead Product Candidate Rejected in August

By Josh Beckerman

Sesen Bio Inc. said it is "pleased" by the meeting it had with the U.S. Food and Drug Administration on Oct. 29 related to an August rejection letter for its lead product candidate Vicineum.

The Type A meeting focused on questions related to Chemistry, Manufacturing and Controls raised in the FDA's Complete Response Letter for the company's Vicineum application for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. There will also be a Clinical Type A meeting.

Sesen "believes it has a clear understanding" of what additional information is required for resubmission.

The FDA also confirmed that Vicineum manufactured using the proposed commercial process is comparable to Vicineum used in prior clinical trials, Sesen said.

In August, Sesen said it was expanding its leadership team in support of its "continued transformation into a commercial-stage company." Shares fell sharply on Aug. 13 following the Complete Response Letter. The stock was recently down 4%, to $1.16.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

11-01-21 1450ET